LIRAGLUTIDE for Obesity

Inclusion criteria

• {"criterion_text":"- \"Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities for the Main phase as well as for the Extension phase of the trial. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial\"\n- Male or female, aged 6 to <12 years at the time of signing informed consent\n- Tanner stage 1-5 pubertal development at the time of signing informed consent\n- BMI ≥95th percentile, on gender and age-specific growth charts (CDC.gov)\n- History of failing to lose sufficient weight with lifestyle modification as judged by the investigator\n- For T2D Haemoglobin A1c (HbA1c) ≤10.0% (86 mmol/mol) as measured by central laboratory at screening"}

Exclusion criteria

• {"criterion_text":"- Nothing written about Key Excl."}

Primary endpoints

• {"endpoint_text":"- Relative change in BMI, from basekline (week 0) to week 56, in Percent","definition_or_measurement_approach":"Relative change in BMI from baseline (week 0) to week 56, measured as percentage change."}

Secondary endpoints

• {"endpoint_text":"- Confirmatory secondary endpoints: Relative change in body weight, from week 0 to week 56 in Percent\n- Subjects achieving ≥5% reduction of BMI, from week 0 to week 56 in, Yes/No\n- Supportive secondary endpoints Effect endpoints: Change in body weight, From baseline (week 0) to week 56, in kg\n- Change in BMI standard deviation score (WHO.int)6, From baseline (week 0) to week 56, Unitless\n- Subjects achieving ≥10% reduction of BMI, From baseline (week 0) to week 56, Yes/No\n- \"BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov), From baseline (week 0) to week 56, in Percent point\"\n- Change in waist circumference, From baseline (week 0) to week 56, in cm\n- Change in systolic blood pressure, From baseline (week 0) to week 56, in mmHg\n- Change in diastolic blood pressure, From baseline (week 0) to week 56, in mmHg\n- Change in HbA1c, From baseline (week 0) to week 56, in Percent point\n- Safety endpoints: Treatment emergent adverse events (TEAEs), From baseline (week 0) to week 82, in Numbers\n- Treatment emergent serious adverse events (SAEs), From baseline (week 0) to week 82, in Numbers","definition_or_measurement_approach":"Secondary endpoints are measured as specified: relative percent change in body weight (week 0 to 56), categorical achievement of ≥5% or ≥10% BMI reduction (Yes/No), absolute change in body weight in kg (baseline to week 56), change in BMI z-score (WHO) unitless (baseline to week 56), BMI as percent of 95th percentile (CDC charts) in percent points (baseline to week 56), waist circumference in cm, systolic and diastolic BP in mmHg, HbA1c in percentage points (baseline to week 56). Safety endpoints (TEAEs and SAEs) are counted from baseline to week 82 and reported as numbers."}

Methods

• Patient recruitment and retention services provided by Jumo Health USA Inc.; specific channels, target audiences and country-specific recruitment approaches are not detailed in the available record.

Portugal

Earliest CTIS Part Ii Submission Date

31-10-2023

Latest Decision Or Authorization Date

08-04-2025

Processing Time Days

525

Number Of Sites

4

Number Of Participants

9

Belgium

Earliest CTIS Part Ii Submission Date

31-10-2023

Latest Decision Or Authorization Date

07-03-2025

Processing Time Days

493

Number Of Sites

2

Number Of Participants

12

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Syneos Health Clinique Inc.

Responsibilities

Special Laboratory

Name

Icon Clinical Research Limited

Responsibilities

Translation

Name

Parexel International (IRL) Limited

Responsibilities

Medical Imaging services

Name

Iqvia Biotech Limited

Responsibilities

Central Laboratory services

Name

Perceptive Eclinical Limited

Responsibilities

Clinical Supplies

Third parties

• {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"Statistical Services","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Special Laboratory","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Clinical Supplies","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient Recruitment and Retention","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Translation","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Medical Imaging services","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"Central Laboratory services","organisation_type":"Pharmaceutical company"}